New Methods for Evaluating Preventive Migraine Treatment (NCT07071506) | Clinical Trial Compass
RecruitingNot Applicable
New Methods for Evaluating Preventive Migraine Treatment
Denmark60 participantsStarted 2025-03-04
Plain-language summary
The study aims to test interactions between drug and placebo-responses in acute migraine treatment and to assess variation in adverse events according to treatment information provided. Using a clinical within-subjects, balanced placebo design, patients with chronic migraine will receive four treatment conditions in a randomized order.
Who can participate
Age range18 Years – 65 Years
SexALL
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Inclusion criteria
✓. Adults (18-65 years)
✓. ≥ 1-year history of migraine with or without aura according to the International Classification of Headache Disorders (ICHD-3) diagnostic criteria
✓. Known chronic migraine (headache occurring ≥ 15 days per month for \> 3 months, which on at least 8 days per month has the features of migraine headache) diagnosed before age 65
✓. Eligibility for preventive migraine treatment
✓. Ability to speak and read Danish
Exclusion criteria
✕. Use of onabotulinumtoxinA as preventive migraine treatment during the 4 months before inclusion
✕. Use of other preventive migraine treatment except CGRP antagonists (However, participants are allowed to be on two stable preventive medication (antidepressant, calcium channel blockers, beta blockers or antiepileptic)- 2 months prior to inclusion until end of study), devices for migraine prevention such as transcranial magnetic stimulation and use of nerve blocks 3 months prior to inclusion
✕. Use of opioid or barbiturate medications in the last four weeks before inclusion
✕. Secondary headache disorders including medication overuse headache
✕. Severe psychiatric, vascular disease, or known liver disease
✕. Alcohol abuse or substance abuse
What they're measuring
1
Mean change in headache intensity
Timeframe: Measured every day during the 8 month trial period
2
Mean change in moderate/severe headache days
Timeframe: Measured every day during the 8 month trial period
3
Adverse events
Timeframe: 24 hours, 14 and 28 days after each treatment administration